Efficacy of Iocide Oral Rinse Against Gingival Inflammation

NCT01782170 | Unknown Phase 2

• 2 other identifiers: UK12-0972-F2LR44HL101821
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the efficacy of Iocide oral rinse in a human clinical trial of gingivitis. Iocide oral rinse will be evaluated against a placebo rinse. Indices for gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine the effect of the antimicrobial oral rinse on relative levels of biological markers of inflammation.

Conditions

Gingivitis; Investigation of Biological Markers of Inflammation

Keywords

Gingivitis; Biomarkers; Biological Markers of Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in Mean Gingival Index (GI)

  Study Days -21 to -7 through Study Day 168

Secondary Outcomes (1)

• Change in Biological Marker Data

  Study Day 1, Day 28, Day 84 and Day 168

Other Outcomes (1)

• Assessment of Product Safety

  Study Days 1 through Study Days 168

Study Arms (2)

Iocide Oral Rinse

ACTIVE COMPARATOR

Iocide Oral Rinse once daily 30 second rinse for 24 weeks

Drug: Iocide Oral Rinse

Placebo Control

PLACEBO COMPARATOR

Once daily 30 second rinse for 24 weeks

Drug: Placebo

Interventions

Iocide Oral Rinse DRUG

Also known as: Iocide Oral Rinse - once daily 30 second rinse for 24 weeks

Iocide Oral Rinse

Placebo DRUG

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or non-pregnant females of at least 18 years of age, and in good general health, as determined by Investigator;
• Have at least 16 natural, gradable teeth and good dental health, as determined by Investigator;
• Have \> 25% sites with Gingival Index (GI) scores of \> 2 at Visits 1 and 2;
• Have Plaque Index (PI) scores of \> 1 on \> 50% of sites;
• Use of effective method of contraception for the duration of the study or permanently sterilized;
• Able and willing to comply with study requirements including following instructions on study treatment and returning for follow-up visits as required by the protocol;
• Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures;
• Females with childbearing potential must have a negative pregnancy test before and during the study period. Sexually active females must be using an effective form of birth control or abstinence. These methods include oral contraceptives ("the pill"), an intrauterine device (IUD), levonogestrol implants (Norplant®), medroxyprogesterone acetate injections (Depo-provera®) or contraceptive foam with a condom.

You may not qualify if:

• History, or current evidence, of any significant acute or chronic subject-reported medical or psychiatric condition that, in the opinion of the Investigator, would render examination difficult or invalid or prevent the subject from active study participation;
• ≤24% of sites with GI score \>2;
• Thyroid peroxidase antibody (TPOab) positive \>34;
• Screening serum level of thyroid stimulating hormone (TSH) \<0.45 or \>4.5;
• Treatment with antibiotic within the one (1) month period prior to the screening examination;
• History of heart murmur, history of rheumatic fever, valvular disease, prosthetic implant or any other condition requiring antibiotic premedication;
• History of thyroid disease;
• Purported sensitivity or allergy to iodine;
• Known sensitivity or allergy to shellfish;
• History of diabetes;
• History of autoimmune disease;
• Gross oral pathology (periodontal disease, rampant caries, tissue damage created by poor oral care or treatment, soft or hard tissue tumors) that, in the opinion of the Investigator, could influence the outcome of the study;
• True periodontal pockets of \> 5 mm and/or visible recession indicative of attachment loss;
• Current signs or symptoms of mucosal tissue ulcerations or inflammation, or canker sores;
• Presence of orthodontic appliances or any removable appliance that impinges on the oral tissues being assessed;

Sponsors & Collaborators

• Biomedical Development Corporation: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Kentucky: collaborator

Study Sites (1)

University of Kentucky, Center for Oral Health Research, College of Dentistry

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dolphus R Dawson III, DMD, MS

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hailey Gallivan, CCRP

CONTACT

859-323-4923; hbwils00@uky.edu

Karl McCloskey

CONTACT

(361) 442-7491; mccloskey@biodevcorp.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: February 1, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

US (1)